Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04499131
Other study ID # 1901-VLC-014-EL
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 9, 2021
Est. completion date December 2024

Study information

Verified date February 2023
Source Instituto Valenciano de Infertilidad, IVI VALENCIA
Contact LAURA CARACENA
Phone 963050999
Email Laura.Caracena@ivirma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After so many years conducting artificial endometrial preparation cycles for embryo transfer, there is no clear indication about which is the optimal dose of exogenous progesterone in this scenario to optimize the outcome. Taking into account that the luteal phase can be controlled by measuring serum P levels (not done until now), the next step is to find out which is the best dose and route of administration of exogenous progesterone for luteal phase in artificial cycles. Therefore, the aim of this experimental study is to compare the endometrial function and structure, as well as the serum P levels according to the use of different types of exogenous progesterone available on the market depending on their doses and route of administration (vaginal, subcutaneous or intramuscular). The endometrial receptivity status will be compared in the different artificial cycles with the one observed in a natural cycle, without exogenous progesterone (only the endogenous one) as a control group. Endometrial receptivity will be analysed by means of endometrial function and structure, but not by pregnancy outcome as in this study an embryo cannot be replaced in the uterus because an endometrial biopsy needs to be done to do this type of research.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria All women with no history of infertility who agree to participate in the study: 1. Age: 18-35 years old, both inclusive 2. Regular menstrual cycles 3. In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study. Exclusion Criteria Subjects who meet one or more of the following will not be considered eligible to participate in the pilot study: 1. Simultaneous participation in other clinical studies that, at the researcher's criteria, could interfere with the results of this study. 2. Taking oral contraceptives in the three months prior to signing informed consent. 3. Presence of uterine pathology (submucosal or intramural myomas >4 cm deforming cavity, endometrial polyps or müllerian anomalies) or adnexal pathology (communicating hydrosalpinx). 4. Background of thrombosis, breast cancer, systemic diseases. 5. Those unable to comprehend the investigational nature of the proposed study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Progesterone
Subjects will undergo an artificial cycle with hormone replacement therapy (HRT) with the aim of comparing the endometrial gene expression profile in the different types of exogenous progesterone with different doses and routes of administration.
Other:
Artificial Cycle (no intervention)
Control group of 15 subjects in the context of a natural cycle with only endogenous progesterone present

Locations

Country Name City State
Spain Instituto Valenciano de Infertilidad Spain Valencia

Sponsors (1)

Lead Sponsor Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endometrial gene expression profile Determination of gene expression 12 months
Secondary Histological dating of endometrial biopsies Endometrial classification using Noyes criteria 12 months
Secondary Histological analysis of the endometrial tissue using electron microscopy Presence or Absence of Pinopodes 12 months
Secondary Progesterone concentration in the endometrium Endometrial progesterone values 12 months
Secondary Serum Progesterone concentrations Blood serum progesterone values 12 months
Secondary Correlation between progesterone levels in blood and uterus. Presence or Absence of correlation 12 months
Secondary Correlation between serum and uterine levels with endometrial transcriptome and histological dating Presence or Absence of correlation 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05969574 - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Recruiting NCT05358483 - PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Completed NCT03177538 - Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders Phase 4
Completed NCT03638856 - Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy N/A
Completed NCT04052464 - The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Withdrawn NCT04753736 - Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC N/A
Completed NCT03349905 - Deferred Versus Fresh Embryo Transfers N/A
Completed NCT05076981 - Progesterone Levels During Ovulation and Luteal Phase
Completed NCT04096027 - Cabergoline Before or After Oocyte Collection for Follicular Resolution Phase 4
Recruiting NCT05980091 - Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration. Phase 1
Terminated NCT01933633 - Improved Fertility After Exercise in Overweight/Obese Women N/A
Terminated NCT01202643 - Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF Phase 1/Phase 2
Completed NCT01202656 - Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization) Phase 1/Phase 2
Completed NCT01408615 - A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
Enrolling by invitation NCT05698550 - The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET Phase 3
Not yet recruiting NCT03910582 - Personalized FET in RIF Patients With Displaced Dating N/A
Completed NCT05440019 - Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
Completed NCT05130125 - Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer